PARAMECTIN 0.08 % W/V DRENCH FOR SHEEP

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

IVERMECTIN

MAH:

Norbrook Laboratories Limited

ATC_code:

QP54AA01

INN:

IVERMECTIN

dosage:

0.8 %w/v

pharmaceutical_form:

Oral Solution

prescription_type:

LM-Licensed Merchant

therapeutic_group:

Ovine

therapeutic_area:

Ivermectin

therapeutic_indication:

Endoparasiticide

authorization_status:

Authorised

authorization_date:

2001-01-12

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Paramectin 0.08% w/v Drench for Sheep.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Ingredient
Ivermectin
0.8 mg
Excipient(s)
Benzyl alcohol (E1519)
0.03 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear yellow pale liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of the following gastrointestinal nematodes, lungworms and nasal bots of sheep.
GASTROINTESTINAL ROUNDWORMS (ADULT AND FOURTH STAGE LARVAE):
_Haemonchus contortus_
[adult, L4 and inhibited L4],
_Ostertagia (Teladorsagia) circumcincta _[adult, L4 and inhibited L4]
_Trichostrongylus _spp
_Cooperia curticei _(adults)
_Cooperia oncophora _[adult and L4]
_Nematodirus _spp including _N. battus_
_Strongyloides papillosus_
_Oesophagostomum columbianum _[adult and L4]
_Oesophagostomum venulosum _(adults)
_Chabertia ovina _(adults)
LUNGWORMS (ADULT AND IMMATURE):
_Dictyocaulus filaria_
NASAL BOT (ALL LARVAL STAGES):
_Oestrus ovis_
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 19/08/2015_
_CRN 7021379_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not use in sheep known to be hypersensitive to ivermectin.
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they increase the risk of development of resistance and
could ultimately result in ineffective therapy:
•
Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
•
Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack